CTRI/2019/10/021723已完成不适用
Comparison between Methotrexate and Apremilast in psoriatic arthritis: A single blinded randomized controlled trial
No sponsor1 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2019年10月31日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- To compare proportions of subjects achieving major cDAPSA response at week 24 between methotrexate and apremilast groups
研究概览
简要总结
Methotrexate has traditionally been the first linechoice for both cutaneous psoriasis and psoriatic arthritis with apremilastbeing a new addition. Various studies showed apremilast being quite efficaciousfor both “treatment modified†and “naïve†psoriatic arthritis patients.However, there is lack of any data regarding head to head comparison betweenthe traditional first line agent, i.e. Methotrexate and apremilast regardingefficacy in psoriatic arthritis patients. In view of paucity of addressing literatureregarding this pertinent issue, the current study was planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age ≥ 18 years.
- •2.Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at time of screening.
- •3.Have ≥ 2 swollen AND ≥ 2 tender joints at randomization.
- •4.Consenting to participate in the study.
排除标准
- •1.Has received study drugs (methotrexate/apremilast) in last 3 months.
- •2.Has received any biological DMARDs (TNFi, IL-12/23 inhibitor, IL-17 inhibitor, CTLA4-Ig) or, other small molecules (JAK inhibitors) ever.
- •3.Recent initiation or a change in the dose of any DMARD in last 3 months prior to randomization.
- •4.Oral steroid dose more than 10 mg/day of prednisolone or equivalent.
- •5.Renal dysfunction (serum creatinine >1.5mg/dl) 6.Liver function abnormality (SGOT and SGPT >2 times upper limit of normal and/or total bilirubin >2mg/dl) 7.Presence of anaemia (haemoglobin <9gm%), leucopenia (<3500/mm3) and thrombocytopenia (<100000/mm3) 8.Presence of comorbid illnesses like major psychiatric disorders, chronic liver disease, cardiac disease, respiratory illness and illicit substance abuse which will hamper the participation of the subject in the study.
- •9.Pregnant or breast-feeding females.
- •10.Females of child bearing potential, not willing to use contraception during study period.
- •11.History of allergy to any component of the study drugs.
- •12.Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV) screening test positivity.
- •13.Presence of active infections, either bacterial, fungal or viral, at randomization or within the last 4 weeks prior to randomization.
- •14.Evidence of active tuberculosis at randomization.
- •15.Active malignancy.
结局指标
主要结局
To compare proportions of subjects achieving major cDAPSA response at week 24 between methotrexate and apremilast groups
时间窗: 24 weeks
次要结局
- 1. ACR 20 at 24 weeks(2. To compare PASI score at 24 weeks)
研究者
研究点 (1)
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